Health Security最新文献

This review is focused on chemical, biological, radiological and nuclear (CBRN) medical countermeasures (MCMs) regulations in the United States between 2014 and 2024. Primary agencies involved in this process include the Food and Drug Administration (FDA), National Institutes of Health, Department of Homeland Security, and Centers for Disease Control and Prevention. Upon emergency declaration by the Secretary of Health and Human Services Emergency Use Authorization (EUA) goes into effect. Current regulation encompasses section 564 of Federal Food, Drug, and Cosmetic Act of 1938) governing EUA and authorizes the FDA to permit the use of unapproved medical products or unapproved uses of approved medical products to diagnose, prevent, or treat serious or life-threatening conditions caused by CBRN threat agents when no adequate, approved, and available alternatives exist. The regulation also includes Animal Rule, which allows pharmaceuticals or biologics licensing based on animal studies when conducting human efficacy studies is unethical. While expedited pathways exist for CBRN EUA, balancing speed and safety considerations is crucial. Priority Review Vouchers can be issued by the FDA to manufacturers for developing medical products during public health emergencies. While these policies and practices have worked well enough, there is room for improvement in the current regulatory framework regarding ongoing innovations, anticipated changes in regulatory policies, and global collaboration efforts. In this article, we discuss various regulatory challenges, including ethical and safety issues to be considered during the approval of MCMs for CBRN threats. Overcoming these challenges necessitates safety and efficacy demonstration of MCMs, maintaining public trust, and striking a balance between speed and safety considerations.

Measles is highly transmissible and can lead to severe complications and mortality risk. Cases of measles are reportable to the US Centers for Disease Control and Prevention (CDC). This study describes characteristics of travelers who flew while infectious with measles and their contacts. We analyzed data from domestic and US inbound international flights reported between January 1, 2018, and December 31, 2019. To identify contacts potentially exposed to measles during air travel we used the CDC-defined measles contact zone and crossmatched with the CDC measles database. We conducted a descriptive analysis of travelers with measles and their aircraft contacts and determined average time from flight exposure to contact interview. During the analysis period, CDC received reports of 83 air travelers infectious with measles resulting in 5,186 potential aircraft exposures. Health departments provided data to CDC for 39% (n=2,037) of the exposures/contacts. On average, 9.8 days elapsed between flight exposure and initial interview attempt. Of the 2,037 contacts interviewed, 82% (n=1,680) reported a history of vaccination or prior disease. Seven secondary cases were identified. Five were exposed on US inbound international flights, 5 had no history of vaccination, and 4 were seated outside the contact zone. Most contacts who developed measles were unvaccinated and shared a US inbound international flight with an infected traveler. Over half of secondary cases were outside the contact zone. The average first contact interview attempt occurred beyond the 3-day window for effective prophylaxis. Continued emphasis on measles vaccination, evaluation of the contact zone definition, and timely contact investigation of exposed travelers may prevent secondary cases and outbreaks in the United States.

This article presents results from The Plant Biomarker Challenge, an initiative funded by the Organization for the Prohibition of Chemical Weapons. The proposed platform-a plant species and measurement methodology-distinguishes between unexposed plants and those exposed to chlorpyrifos, a model organophosphorus pesticide. These compounds are active ingredients in pesticides and chemical warfare agents. Plants expressing acetylcholinesterase activity are affected by such compounds and can serve as biomarkers for accidental or criminal exposures, which is the focus of this study. An electrochemical method is proposed to assess pesticide exposure by analyzing alterations in acetylcholinesterase enzymatic activity. Initial assays in aqueous phase validate the mechanism, complemented by infrared spectrometry, before transitioning to plant samples. Chicory extracts exposed to varying chlorpyrifos concentrations are analyzed, enabling differentiation between nonexposed plants and those subjected to doses exceeding one-tenth of the manufacturer's recommended mean dose. Electrochemical impedance spectroscopy evaluates acetylcholinesterase activity indirectly via its reaction with acetylthiocholine chloride and the subsequent interaction between generated thiocholine and silver nanoparticles. This comprehensive system integrates plant species and a measurement method to detect environments exposed to organophosphates.

Marking the 50th anniversary of the Biological Weapons Convention (BWC), this commentary examines adaptive strategies underpinning the treaty's resilience within an increasingly complex and fragmented global biosecurity ecosystem. By conceptualizing the BWC as an autopoietic subsystem-one that is self-sustaining and yet structurally coupled to its environment-we argue that the BWC's historical effectiveness in preventing large-scale biological weapons use derives from its capacity for normative memory. Its reflexive operation enables the treaty to continuously reinterpret and apply its foundational prohibition amid evolving scientific and technological landscapes. Recent advancements in synthetic biology, bioinformatics, and artificial intelligence intensify risks by blurring boundaries between biosafety and biosecurity, between peaceful and weaponized biotechnology applications, challenging the BWC's ability to differentiate clearly between permissible and prohibited activities. In response, internal structural differentiation through specialized frameworks becomes essential, notably via the proposed science and technology mechanism. This body would function explicitly as a structural coupling device, mediating uncertainty and translating the flux of scientific possibility into legally referable categories without collapsing the normative autonomy of the Convention. Concurrently, the international cooperation and assistance mechanism would enhance global preparedness and interoperability among cross-disciplinary biosecurity communities. The COVID-19 pandemic underscored the urgency for institutional adaptability, heightened preparedness, and proactive engagement across disciplines. Analyzing ongoing diplomatic negotiations within the Working Group on the Strengthening of the BWC, we highlight substantial convergences alongside residual divergences across 7 key topics: international cooperation and assistance; science and technology; compliance and verification; confidence-building measures; assistance, response and preparedness; national implementation; and organizational, institutional, and financial arrangements. Ultimately, we advocate for integration of scientific expertise and diplomatic practice, emphasizing sustained interdisciplinary collaboration and robust institutional commitment as prerequisites for ensuring the BWC's normative vitality and operational efficacy for decades to come.

For over half of its lifespan, the Biological Weapons Convention (BWC) operated without any dedicated continuous institutional support. This shortcoming was finally remedied at the Sixth Review Conference in 2006, not long after the convention's 30th anniversary. The Implementation Support Unit (ISU) created by that Review Conference has now been in existence for almost 2 decades. This year also marks the 50th anniversary of the convention-an appropriate moment to make some observations on the contribution of the ISU to the overall development of the BWC. In this commentary, we examine the efforts made over the years to equip the BWC with stronger institutional support and provide a description of the establishment of the ISU in 2006. We also summarize some key achievements of the ISU alongside some of the challenges that it has faced. Finally, we conclude with reference to the ongoing discussions within the Working Group on the Strengthening of the Convention to endow it with a more robust institution.

This study evaluates South Korea's legislative amendments related to infectious disease after the 2015 Middle East respiratory syndrome (MERS) outbreak and how they were applied during the COVID-19 pandemic. A significant legal case after the 2015 MERS outbreak highlighted the government's liability due to inadequate response, which led to amendments in the Infectious Disease Control and Prevention Act. Key revisions included changes to epidemiological investigations, information disclosure, and requests to provide information. This study reviews the application of these amendments during COVID-19, focusing on related litigation and Korean courts' decisions. Additionally, it examines South Korea's efforts after COVID-19, which aim to balance effective infectious disease responses with personal information protection, incorporating lessons from past outbreaks. The study concludes that continuous legal and systemic improvements focused on the specific circumstances are crucial for managing future infectious disease crises, highlighting the need for a legal framework that maximizes the beneficial aspects of being able to curb the spread of infectious disease while minimizing the problematic issue of personal information infringement.

The COVID-19 pandemic exposed vulnerabilities in health systems' abilities to detect, report, and respond to threats. Inadequate preparedness led to healthcare worker infections, essential service disruptions, and impacts on communities. Primary healthcare (PHC) is often overlooked in health security initiatives. Epidemic Ready Primary Health Care (ERPHC) is an initiative that strengthens PHC facilities to prevent, detect, and respond to outbreaks, while maintaining essential services. ICAP at Columbia University, the Sierra Leone Ministry of Health, and Resolve to Save Lives is implementing a multiyear ERPHC project in Sierra Leone. We conducted a retrospective data review of 52 confirmed measles cases across 4 PHC facilities from January to March 2024. Data are presented using an adapted 7-1-7 quality improvement approach for detection and notification to evaluate the key tenants of ERPHC: speed, safety, and surge. Out of the 52 confirmed cases, 98% and 100% met the first "7" and "1" for detection and notification. Immediate case management and safety actions were completed for all 52 cases. None of the facilities were able to implement 2 readiness parameters for surge: sufficient supplies and referral pathways. Key bottlenecks included patient late presentation to health facilities, delayed notification via the electronic case-based surveillance system, inadequate personal protective equipment availability, and no updated referral pathways. These results underscore the need to scale and implement ERPHC in PHC facilities using adapted 7-1-7 metrics. Healthcare worker safety, increased community engagement, national supply chain mechanism strengthening, and established patient referral pathways need to be the foci of further health security investment in Sierra Leone.

The Biological and Toxin Weapons Convention (BWC) celebrates its 50th anniversary in 2025, a historical milestone for the first treaty to ban an entire class of weapons. Despite major shortcomings and barriers, the BWC remains a stalwart bulwark against the deliberate misuse of biology. In this special feature, experts from around the world highlight critical challenges and opportunities for the BWC, honoring the treaty's first half-century and drawing lessons from past experiences, but more importantly, looking ahead to envision the next 50 years of biological weapons disarmament and nonproliferation.

Biological weapons can take many forms and have been designed for a variety of purposes, including-but not limited to-attacks on human populations. The 1972 Biological Weapons Convention has played a key role in the comprehensive prohibition and prevention of such weapons over the past 50 years. To sustain this prohibition into the future, states parties to the treaty must carefully monitor advances in science and technology, while also remaining vigilant against the risks posed by older, outdated forms of biological weapons.

In the absence of formal inspection protocols, states parties of the Biological Weapons Convention (BWC) continue to trade unsubstantiated accusations undermining confidence in the BWC and fueling geopolitical distrust. This commentary argues that open-source intelligence (OSINT) offers a vital, albeit imperfect, solution to enhance BWC compliance in this environment. It also discusses 2 primary ways OSINT can contribute. First, by providing transparent, verifiable evidence to support or refute compliance allegations, OSINT can mitigate credibility challenges associated with state-issued intelligence. This is made possible by ever-expanding publicly available data streams from high-resolution satellite imagery to publication and patent databases and publication records. Second, OSINT empowers civil society organizations to monitor bioscience activities, expose suspected violations, and exert public pressure for accountability. Although OSINT cannot fully substitute for onsite inspections or confirm intent, embracing OSINT as both a technical resource and an advocacy tool offers a practical pathway to strengthen BWC compliance and reinforce the norm against biological weapons.